Policy for the control and management of Tuberculosis (TB) including multi-drug resistant Tuberculosis (MDR-TB).

Transcription

1 Policy for the control and management of Tuberculosis (TB) including multi-drug resistant Tuberculosis (MDR-TB). Author: Responsible Lead Executive Director: Endorsing Body: Governance or Assurance Committee TB Contact Tracing Service Health Protection Team Director of Public Health Health Protection Committee Implementation Date: December 2014 Version Number: V0.5 Review Date: December 2016 Responsible Person Healthcare Quality Assurance & Implementation Committee Dr Josephine Pravinkumar Version No.0.5 December 2014 Page 1 of 17

2 CONTENTS i) Consultation and Distribution Record ii) Change Record 1. INTRODUCTION 2. AIM, PURPOSE AND OUTCOMES 3. SCOPE 4. PRINCIPLE CONTENT 4.1 Case definitions 4.2 Risk Assessment & diagnosis 4.3 Multi-drug resistant TB and Extremely drug resistant TB 4.4 Laboratory reporting & Public Health Notification 4.5 Treatment of TB 4.6 Management of Contacts & Screening 4.7 Vaccination 4.8 In- patient management (infection control) 4.9 Tuberculosis and Health Care Workers 5. TUBERCULOSIS in Prisons and other custodial settings 6. ROLES AND RESPONSIBILITIES 7. RESOURCE IMPLICATIONS 8. COMMUNICATION PLAN 9. QUALITY IMPROVEMENT MONITORING AND REVIEW 10. EQUALITY AND DIVERSITY IMPACT ASSESSMENT 11. REFERENCES 12. APPENDIX 1 - Referral Pathway Tuberculosis Clinic Version No.0.5 December 2014 Page 2 of 17

3 Contributing Author / Authors CONSULTATION AND DISTRIBUTION RECORD Christine Weir Lesley Ritchie Dr Josephine Pravinkumar Lindsay Guthrie Consultation Process / Stakeholders: Consultants Public Health Medicine Infectious Diseases Consultants Respiratory Consultants Microbiologists Laboratory staff Infection Prevention and Control Team Health Protection Nurses General Practitioners SALUS Occupational Health and Safety Health Visitors School Nurses Pharmacists Pathologists HMP Shotts Dungavel Immigration & Detention Centre Distribution: NHS Lanarkshire intranet First Port NHS Lanarkshire internet CHANGE RECORD Date Author Change Version No. 28/04/2014 L. Guthrie Content revised & updated. New policy V0.1 template applied 12/08/2014 L. Guthrie Updated to reflect comments received in V0.2 consultation 29/10/2014 L. Guthrie Final draft version for approval V0.3 26/11/2014 L. Guthrie Final version for approval V0.4 08/12/2014 L. Guthrie Information about laboratory testing clarified. Final version for approval V0.5 Version No.0.5 December 2014 Page 3 of 17

4 1. INTRODUCTION This policy has been developed for use in NHS Lanarkshire as part of the Control of Infection policy manual. This policy should be read in conjunction with the following policies: Chapter 1- Standard Infection Control & Transmission Based Precautions Section O Last Offices Policy 2. AIM, PURPOSE AND OUTCOMES To ensure that patients receive appropriate and timely investigation, care and treatment in line with current national guidelines and best practice. To ensure that NHS Lanarkshire staff are aware of the need to identify patients at risk of having or who have Tuberculosis (TB), and take early action to involve the health protection team to prevent disease progression and transmission of this disease. To identify, screen and treat those individuals at risk of acquiring TB following close contact with a known case. 3. SCOPE This policy is designed to safeguard patients, staff and the wider public from the risk of Tuberculosis. The policy is aimed at healthcare staff working in NHS Lanarkshire, but particularly: Infectious Diseases Consultants Respiratory physicians General Practitioners Respiratory ward staff Infectious diseases unit staff Infection Prevention & Control Team Health Protection Team Emergency Departments Emergency Receiving Units Coronary Care Units (CCU s) Theatres / Bronchoscopy unit Version No.0.5 December 2014 Page 4 of 17

5 4. PRINCIPLE CONTENT Tuberculosis (TB) is a bacterial disease caused by infection with the Mycobacterium tuberculosis complex or organisms (M. tuberculosis, M. bovis, M. africanum, M. microti). These may cause pulmonary (respiratory) and / or non-pulmonary tuberculosis. Tuberculosis is curable and preventable. Pulmonary TB is defined as active disease affecting any of the following: lungs pleural cavity mediastinal lymph nodes larynx Non-pulmonary TB commonly affects: Lymph nodes Bowel Peritoneum Meninges Kidneys Bones & joints People infected with TB bacteria have a 10% lifetime risk of falling ill with TB. However persons with compromised immune systems, such as people living with HIV, malnutrition or diabetes, or smokers, have a much higher risk of falling ill. Following treatment, there is a risk of the disease being reactivated. Table 1: Summary Causative organism Mycobacterium tuberculosis Mycobacterium bovis Mycobacterium africanum Mycobacterium microti Clinical Can be asymptomatic manifestation Early symptoms include: Fatigue Weight loss Night sweats Fever Later disease usually presents with: Cough (usually productive) Haemoptysis (coughing up blood) Chest pain Hoarseness Dysphagia (difficulty swallowing) Incubation period 3-8 weeks (can be up to 12 weeks) Period of infectivity Latent phase (where the person is not infectious but asymptomatic) can last decades Whilst sputum smear positive (e.g. there are viable organisms in the sputum) Version No.0.5 December 2014 Page 5 of 17

6 Usually until at least 2 weeks of compliant chemotherapy completed, however, this will depend on the initial bacterial load and response to treatment Mode of Airborne transmission Reservoirs Most common source is infected humans Infected cattle or cats(rarely) Population at risk Individuals who are: Immunosuppressed Problem alcohol users Malnourished Have a history of substance abuse Elderly New entrants from high risk countries Healthcare workers Veterinary workers Close contact of case of TB Vaccine Yes. preventable Routine vaccination stopped in 2005 and is now offered only to high risk individuals See The Green Book Notifiable disease Yes 4.1 Case definitions Table 2: Case definitions Definition Criteria Confirmed case Probable case Possible case Latent TB Sputum smear positive Sputum smear negative An individual with a positive laboratory culture confirmed disease due to M. tuberculosis, M. bovis, M. microti or M. africanum. In the absence of culture confirmation, an individual with: Signs and/or symptoms compatible with tuberculosis AND Treatment with 2 or more antituberculin drugs AND Microscopic or histological evidence of mycobacterial infection OR A positive tuberculin test In the absence of culture confirmation, an individual with: Microscopic or histological evidence of mycobacterial infection or a positive tuberculin test OR Signs and/or symptoms compatible with tuberculosis, OR Treatment with 2 or more anti-tuberculous drugs Known contact with a case of TB Where an individual is infected with TB, but is asymptomatic. Individuals with a positive IGRA test. Acid alcohol fast Bacilli (AAFB) can be seen using a stain on a film of sputum in at least 1 or more samples obtained 24hours apart. No bacteria can be seen on the staining of 3 sputum samples obtained 24 hours apart. Version No.0.5 December 2014 Page 6 of 17

7 4.2 Risk Assessment & diagnosis Risk Assessment A diagnosis of TB should be considered in ANY patient presenting with symptoms of fatigue, weight loss, night sweats or fever. Clinicians should consider TB as a diagnosis in those patients with other risk factors, including: Human Immunodeficiency virus (HIV) Malnutrition Alcohol or substance abuse Immigration from a high risk country where TB incidence >40 per 100,000 (as per WHO data) Healthcare work Veterinary work Elderly Contact of a case of TB Clinicians are encouraged to send samples even if the clinical suspicion of infection is low. All cases of suspected tuberculosis (clinical suspicion) MUST be notified to the Consultant in Public Health Medicine (CPHM) Diagnosis Active pulmonary TB can be diagnosed using: anterior chest X-ray serial sputum samples for microscopy & culture (including at least 1 early morning sample) induced sputum samples (if spontaneous sputum not produced) bronchial washings or biopsy from bronchoscopy gastric washings (in children only) Active non-pulmonary TB can be diagnosed using: lymph node biopsy pus aspirated from lymph nodes pleural biopsy any surgical sample sent for routine culture any radiological sample sent for routine culture histology sample aspiration sample post-mortem sample Non respiratory samples should be sent to the laboratory in dry sterile containers for TB microscopy and culture. Patients diagnosed with non-pulmonary TB should also have a chest x-ray to confirm or exclude respiratory TB infection. Version No.0.5 December 2014 Page 7 of 17

8 Initial samples should be sent to the microbiology laboratory at Hairmyres Hospital for Alcohol and Acid Fast Bacilli (AAFB) microscopy and culture. Rapid molecular diagnostic testing/confirmatory testing will be arranged for all positive samples or complex samples at the Scottish Mycobacterial Reference Laboratory (SMRL) in Edinburgh. Latent TB is usually diagnosed using a Tuberculin skin test (usually a Mantoux test). An interferon-gamma release assay (IGRA) blood test may be used in the diagnosis of latent TB. Post mortem diagnosis may also be made. Post mortem samples should be sent for TB microscopy & culture in a dry sterile container (no formalin). 4.3 Multi-drug resistant TB and Extremely drug resistant TB Globally, there has been an emergence of strains of TB which are multi-drug resistant (MDR-TB) and extremely drug resistant (XDR-TB). This provides further challenges in treating and controlling cases of TB. The possibility of drug resistant TB should be considered if there is: history of incomplete or non compliant treatment contact with an individual with known drug resistant TB disease probably acquired in country with high incidence of drug resistance disease not responding to treatment 4.4 Laboratory reporting & Public Health Notification TB is a notifiable disease under the Public Health (Scotland) Act Registered medical practitioners are required to report TB based on clinical suspicion and is not dependent on laboratory confirmation. Notification of active TB must be made within 24 hours of diagnosis to allow appropriate assessment & contact tracing to be arranged. Notification should be made by telephone in the first instance to the Consultant in Public Health medicine (CPHM). Tel: (Mon-Thurs 09:00-17:00, Fri 09:00-16:30) or (Out of Hours) The Tuberculosis Contact Tracing Service (TBCTS) as part of the Department of Public Health monitor the incidence of TB through formal surveillance systems. Laboratories must also report any smear positive or culture positive samples to the CPHM. All cases reported must be followed by written notification using part A of the Enhanced Surveillance of Mycobacterial Infections in Scotland (ESMI) form. Version No.0.5 December 2014 Page 8 of 17

9 To prevent further transmission of the disease, the TB nurses will carry out a risk assessment and undertake case contact tracing. Overall the risk of the contacts of a case developing TB is low. The highest risk is amongst household members. Therefore ALL household contacts of an active case of TB will be screened, irrespective of the site of infection. 4.5 Treatment of TB The treatment of patients with TB should be referred to; and managed by; a physician (or paediatric physician) with expertise and experience in managing this disease without delay. All patients in NHS Lanarkshire with suspected TB should be referred to the specialist TB clinic at Monklands Hospital. Please see Appendix 1 for referral pathway. Most individuals with TB can be managed in the community. Hospital admission is usually not necessary and should be avoided unless there is an overriding medical or social reason. The standard recommended regimen for TB is a combined drug treatment comprising of: Isoniazid (for 6 months) Rifampicin (for 6 months) Pyrazinamide (for first 2 months of treatment) Ethambutol (for first 2 months of treatment) Non compliance with drug treatment is the most important cause of treatment failure. All patients should be risk assessed to consider if they can/will adhere to treatment. If poor compliance is anticipated, for example due to lifestyle or mental health issues, patients should be managed using Directly Observed Therapy (DOT). This should be discussed with the TBCTS before treatment is commenced. This ensures that a healthcare professional or other suitable person observes that the medication is swallowed. Version No.0.5 December 2014 Page 9 of 17

10 Table 3: Treatment of Tuberculosis Type of Tuberculosis Respiratory Meningeal Peripheral lymph node Drug regime Standard recommended regimen Standard recommended regimen PLUS Isoniazid and Rifampicin for a further 6 months(12 month total treatment) PLUS a glucocorticoid at the normal dose range Adults equivalent to prednisolone 30-40mg if on Rifampicin, otherwise 10-20mg Children equivalent to prednisolone 1-2 mg/kg/day (maximum 40mg/day) Gradual withdrawal of glucorticoid within 2-3 weeks of starting treatment Standard recommended regimen Other treatment (consider) Bone & joint Standard recommended regimen Consider CT or MRI scans if active spinal TB and neurological symptoms present. Pericardial Disseminated (Miliary) Standard recommended regimen PLUS a glucocorticoid: Adults equivalent to prednisolone 60mg/day Children equivalent to prednisolone 1mg/kg/day (maximum 40mg/day) Gradual withdrawal of glucorticoid within 2-3 weeks of starting treatment Standard recommended regimen Consider spinal fusion if there is spinal instability or evidence of spinal cord compression Version No.0.5 December 2014 Page 10 of 17

11 4.6 Management of Contacts & Screening Overall the risk of contacts of a case developing TB is low. A contact of a case of TB is defined as any individual who has had prolonged close contact with the index case in a household setting during the seven days before the onset of illness. Examples of a household contact include: living or sleeping in the same household (including extended household) boyfriends/girlfriends sharing a dormitory, flat or hospital ward with the index case. sharing a kitchen in a hall of residence Other contacts (e.g. work, school) are not usually considered close contacts, but will be individually risk assessed by the TB nurse specialists/health Protection Team. This will include consideration of: degree of infectivity of the index case the length of time the index case was in contact with others the health status/susceptibility to infection of the contact, and the proximity of contact Timescales for screening High risk contacts (including children, individuals with symptoms, or where the index case has had a long history of untreated infection) should be screened within 7 days. Screening should be offered to the household contacts of a person with TB (irrespective of whether it is respiratory or non respiratory TB) within 6 weeks of being identified Screening Methods The principal method of screening is a Mantoux test. This test provides an indication of past infection or successful immunisation, by detecting the presence of proteins produced as part of the body s immune response to TB infection. This is generally used in children and adults 35 years. Mantoux testing must only be carried out by staff who have received specific instruction and training in the administration and interpretation of the test. An interferon-gamma release assay (IGRA) blood test may be used in the diagnosis of both active and latent TB. At present, this is reserved for use in individuals over 16years of age, and large scale contact tracing exercises only. Version No.0.5 December 2014 Page 11 of 17

12 4.7 Vaccination Bacillus Calmette-Guerin (BCG) is a live attenuated vaccine which provides good protection against M. tuberculosis. The vaccine is 70-80% effective against the most severe forms or TB, such as meningitis in children. It is less effective in preventing respiratory disease, which is the most common form in adults. The aim of vaccination is to prevent those who are at increased risk of developing severe disease and/or of exposure to TB infection. Following decline in the number of cases of TB in the UK, routine immunisation against TB was stopped in 2005, and is now offered on risk assessment. BCG Vaccination and recommendations for vaccination should be carried out in line with The Green Book: Chapter In- patient management (infection control) Clinical staff should liaise with the hospital Infection Prevention and Control Team (IPCT) to risk assess each patient with suspected or known TB on each admission. This should include consideration of current clinical status (smear positive/negative), risk of MDR-TB and type of clinical intervention required. The principle measures to reduce exposure in healthcare settings are: early isolation; early diagnosis; and early commencement of therapy. In addition to standard infection control precautions (SICPs), staff caring for patients with TB should apply transmission based precautions (TBPs) (airborne and contact precautions) until ALL of the following conditions are all met: the patient has had a minimum of 14 days of appropriate therapy the patient has had at least 3 consecutive negative sputum smears taken on separate days, or complete resolution of cough the patient has had a definite clinical improvement as a response to therapy (e.g. remaining afebrile for 1 week) the patient has demonstrated tolerance to therapy and ability to agree to adhere to treatment, and advice has been sought from a member of the IPCT before removing a patient from isolation. The IPCT should ensure that the patient is not placed beside patients who are known to be immunocompromised. If a patient is retrospectively diagnosed following a hospital admission, the Infection Prevention & Control Team will undertake appropriate investigation and risk assessment with input from the TB service. This is to ensure that any patients, staff or others who may be at risk are identified and followed up in a timely manner. Any such contacts identified will be followed up in line with this policy. Version No.0.5 December 2014 Page 12 of 17

13 Table 4: Infection Control Precautions TB Infection control precaution Patient placement Respiratory PPE Non-pulmonary TB Isolation not required unless risk assessment demonstrates otherwise Not required Pulmonary TB (suspected or currently smear positive) Single room (door kept closed) preferably negative pressure or with external air venting UNTIL: 2 weeks compliant treatment completed AND sputum smear negative Surgical masks for routine contact during care. Multi-drug resistant TB (suspected or confirmed) Single room with negative pressure FFP3 masks for all contacts by staff Cough hygiene As per SICPs FFP3 masks required for: aerosol generating procedures (AGPs) the total nursing contact time is likely to be 8 hours or more Encourage patient to cover mouth & nose with disposable tissue when coughing. Visitors should wear masks where possible use FFP3 (with appropriate fit testing). Encourage patient to cover mouth & nose with disposable tissue when coughing. Equipment & Environmental cleaning Visitors As per SICPs No restrictions on visitors. The patient should be asked to wear a surgical mask if leaving their room within the first 2 weeks of treatment. Minimum of daily cleaning of all equipment & environment with a solution of 1,000ppm av. Hypochlorite. Disposable or dedicated equipment clean as above after each use. Limit to those who were previously in close contact before diagnosis Visitors to children with TB must be kept away from other patients until risk assessed &excluded as a source of infection Strictly limit visitors to minimum. Visitors should wear masks (see PPE above) Linen As per SICPs As per SICPs As per SICPs Waste As per SICPs As per SICPs As per SICPs Hand hygiene As per SICPs As per SICPs As per SICPs Body fluid spills As per SICPs As per SICPs As per SICPs Version No.0.5 December 2014 Page 13 of 17

14 4.9 Tuberculosis and Health Care Workers All NHS employees must complete pre-employment screening/checks to confirm their TB status and vaccination history prior to taking up their role. Staff who work with: patients known or suspected to have TB clinical material in the laboratory prisoners the elderly in care homes homeless people, asylum seekers or refugees are more likely than others in the general population to come into contact with someone with TB. Individuals with signs or symptoms of TB should not work directly with patients until they have been seen and treated as appropriate. The risk of TB for a new healthcare worker who is HIV positive at the time of recruitment should be assessed as part of preemployment health screening. If there is no evidence of prior screening or previous immunisation (BCG), any member of staff transferring with the NHS board should be treated as a new employee for risk assessment purposes. Healthcare staff should practise Standard Infection Control Precautions (SICPS) when carrying out any care or procedure with all patients. This includes the appropriate use of personal protective equipment (PPE) Healthcare worker exposure If a patient is suspected to have TB, staff should use appropriate face masks and other PPE in line with table 4 and refer to Chapter2 National Infection Prevention & Control Manual (Transmission Based Precautions) for further information if required. If healthcare staff involved in the care of a patient who is subsequently found to be smear positive for TB, AND where appropriate PPE has not been used as per policy, the member of staff should be assessed and referred to SALUS Occupational Health & Safety. 5. Tuberculosis in Prisons and other custodial settings It is the responsibility of the healthcare team where the patient is based (e.g. HMP Shotts) to identify any potential cases and manage their care in line with local guidance and policy. The provision of PPE and general advice for staff is also the responsibility of local management. Version No.0.5 December 2014 Page 14 of 17

15 Key actions include: any prisoners with a cough of more than three weeks duration must be medically assessed for tuberculosis prisoners with suspected or confirmed pulmonary TB must be isolated in a single cell until considered no longer infectious the TB service must be informed as soon as possible the TB service will determine, in liaison with the prison healthcare team, the extent of any contact tracing and screening necessary all prisoners being treated for TB (or latent TB infection) must have directly observed therapy (DOT) TB treatment and management should be supervised by the TB service. prisoners on TB treatment must be placed on medical hold until they have been established on the appropriate TB treatment and are considered to be no longer infectious continuity and completion of treatment is paramount. Close liaison with the TB service must take place to ensure treatment on leaving the prison. 6. ROLES AND RESPONSIBILITIES All staff are responsible for implementing and following the advice provided in this policy. 7. RESOURCE IMPLICATIONS There may be resource implications (financial and staffing) to ensure that appropriate arrangements are made for an adequate number and range of staff successfully undergo face fit testing for FFP3 masks. 8. COMMUNICATION PLAN This policy is available on NHS Lanarkshire intranet. Changes to policy or guidance will be communicated to key personnel via: Discussion at departmental meetings Note on staff briefing on First Port Educational sessions 9. QUALITY IMPROVEMENT Monitoring and Review Compliance with this policy will be monitored by the Infection Control team and Health Protection Team 10. EQUALITY AND DIVERSITY IMPACT ASSESSMENT This policy meets NHS Lanarkshire s EDIA Version No.0.5 December 2014 Page 15 of 17

16 11. Summary or Frequently Asked Questions (FAQs) (tick box) If you have any questions about this policy or how to implement it, please refer to the Tuberculosis page on Firstport, or contact the TB contact tracing service to discuss your query. 12. REFERENCES NICE (2011) Clinical diagnosis and management of tuberculosis, and measures for its prevention and control HPN (2009) Tuberculosis: Clinical diagnosis and management of tuberculosis, and measures for its prevention and control in Scotland HPS (2014) National Infection Prevention & Control Manual Scottish Government (2013) CMO (2013)21Publication of Scottish TB action plan Public Health England (2013) Screening for tuberculosis (TB) in prisons, treating TB and reporting cases - guidance for prison healthcare teams. guidance_for_prison_healthcare.pdf The Green Book (2014) Immunisation against infection disease Version No.0.5 December 2014 Page 16 of 17

17 TB REFERRAL PATHWAY Management of Tuberculosis Appendix 1: Referral Pathway Tuberculosis Clinic Consider symptoms General: Fever Night sweats Weight loss Anorexia Malaise Pulmonary Cough>3weeks with/without sputum Haemoptysis Spinal Back pain Lymph node Enlarged nodes > 4 weeks (nodes may discharge) Other possible sites Abdominal/GU etc. If above tests are negative, refer patient to appropriate: Weekly Respiratory Clinic at: Hairmyres, Wishaw General or Monklands as per routine procedure or to general I.D. Clinic at Monklands Do the following investigations (adult patients only): Chest X-ray 3 fresh, sputum samples (ideally 5ml or greater) collected at intervals of 8 24 hours, including at least one early morning sample 3 early morning urine samples (collected on consecutive days in sterile universal containers) Biopsy e.g. lymph node (ensure material is sent for TB culture and histology) Patient requires treatment for TB if: Smear positive for TB or Histology positive for MTB or Culture positive for MTB or Latent TB (selected cases) If in doubt discuss with TB Clinician Consider risk factors Close contact of TB Case Alcohol/drug dependent Born in high incidence country Immunocompromised Homeless Suspected incomplete TB treatment Refer to TB Clinic and define urgency of referral If patient is systemically unwell, if there is suspected CNS involvement, or suspected spinal TB with neurological symptoms, discuss admission with TB Clinician Make referral to: Contact TB Nurses for support if required for example:- if patient is difficult to engage or unlikely to attend Tel: For Adults Refer to: Tuberculosis Clinic Infectious Diseases Unit, Monklands Hospital, Monkscourt Ave, AIRDRIE, ML6 0JS Tel: /5 Fax: For Children under 16 Refer to: Paediatric Dept. Wishaw General Hospital 50 Netherton Street, WISHAW, ML2 0DP Tel: / Fax: Version No.0.5 December 2014 Page 17 of 17